BEUDAMED
    9 results · 25ms · Sources: EU EUDAMED, US FDA

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    THERA-FIT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Nu-Edge Cobalt Chromium Brackets

    FDA UDI
    TP ORTHODONTICS INC·00192029045763·LL 2nd BI W/HK

    INTEL-GE CARE INNOVATIONS CONNECT RCM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SIMUPLAN TREATMENT PLANNING SYSTEM, MODEL V. 7.5

    FDA 510(k)
    FDA Class 2 ·Radiology

    HU-FRIEDY PERMA SHARP SUTURES

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)·Product code GAR·May 26, 2010

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 28, 2013

    RENAL - DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·December 16, 2010

    SENSOR ENLITE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·July 12, 2014

    EndoVive 3s Low Profile Balloon Kits Part Number: M00548240 (XMD P/N 70-0050-312) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

    FDA Enforcement
    Class II ·Terminated·Xeridiem Mediem Medical Devices Inc·March 2, 2016